Means and method for reversibly connecting a patch to a patch deployment device

ABSTRACT

The present invention generally relates to devices and methods for reversibly coupling an implant to a deployment device.

RELATED APPLICATION

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 12/834,456, filed Jul. 12, 2010, which is acontinuation-in-part of PCT international patent application numberPCT/IL2009/000188, filed Feb. 18, 2009, which claims the benefit of andpriority to U.S. provisional patent application Ser. No. 61/029,386,filed Feb. 18, 2008. The present application also claims the benefit ofand priority to U.S. provisional patent application Ser. No. 61/302,186,filed Feb. 8, 2010. The content of each of these is incorporated byreference herein in its entirety.

FIELD OF THE INVENTION

This invention generally relates to a device and method for reversiblycoupling a patch to a patch deployment device.

BACKGROUND

An object of the present invention is to provide apparatus and a methodfor performing corrective surgery on internal wounds such as herniawhere invasion of the patient's body tissues is minimized and resultanttrauma is reduced.

A hernia is a protrusion of a tissue, structure, or part of an organthrough the muscular tissue or the membrane by which it is normallycontained. In other words a hernia is a defect in the abdominal wallthrough which a portion of the intra-abdominal contents can protrude.This often causes discomfort and an unsightly, visible bulge in theabdomen. When such a hernia defect occurs in the abdominal region,conventional corrective surgery has required opening the abdominalcavity by surgical incision through the major abdominal muscles. Whilethis technique provides for effective corrective surgery of the herniadefect, it has the disadvantage of requiring a hospital stay of as muchas a week, during which pain is frequently intense, and it requires anextended period of recuperation. After the conventional surgery patientsfrequently cannot return to a full range of activity and work schedulefor a month or more. Accordingly, medical science has sought alternativetechniques that are less traumatic to the patient and provide for morerapid recovery.

Laparoscopy is the science of introducing a viewing instrument through aport into a patient's body, typically the abdominal cavity, to view itscontents. This technique has been used for diagnostic purposes for morethan 75 years. Operative laparoscopy is performed through tiny openingsin the abdominal wall called ports. In most surgical techniques severalports, frequently three to six, are used. Through one port is insertedthe viewing device, which conventionally comprises a fiber optic rod orbundle having a video camera affixed to the outer end to receive anddisplay images from inside the body. The various surgical instrumentsare inserted through other ports to do the surgery that normally wouldbe performed through an open incision through the abdominal wall.Because the laparoscopic surgical techniques require only very smallholes through the abdominal wall or other portions of the body, apatient undergoing such surgery may frequently leave the hospital withinone day after the surgery and resume a full range of normal activitieswithin a few days thereafter.

In repairing hernia the physician needs to first deploy the patch andthen to attach the patch to the tissue.

There are many patents and patent applications relating to attaching aprosthesis implant to a tissue via tacks. Each patent and patentapplication describes a different attachment mechanism via differentanchoring means (see for example U.S. Pat. No. 6,447,524). Traditionalanchors used in surgery include clips, staples, or sutures, and may alsobe referred to as tissue anchors. These devices are usually made of abiocompatible material (or are coated with a biocompatible material), sothat they can be safely implanted into the body.

Most tissue anchors secure the tissue by impaling it with one or moreposts or legs that are bent or crimped to lock the tissue into position.Thus, most traditional anchors are rigid or are inflexibly attached tothe tissue. For example PCT no. WO07/021,834 describes an anchor havingtwo curved legs that cross in a single turning direction to form a loop.Those two curved legs are adapted to penetrate tissue in a curvedpathway. U.S. Pat. No. 4,485,816 (refers hereinafter as 816′) describessurgical staple made of shape memory alloy. The staple is placed incontact of the tissue and then heated. The heating causes the staple tochange its shape thus, penetrating the tissue.

U.S. Pat. No. 6,893,452 describes a tissue attachment device thatfacilitates wound healing by holding soft tissue together under improveddistribution of tension and with minimal disruption of the woundinterface and its nutrient supplies.

U.S. Pat. No. 6,517,584 describes a hernia patch which includes at leastone anchoring device made of shape memory material. The anchoringdevices are initially secured to the prosthesis by being interlacedthrough a web mesh constituting the prosthesis. The attachment isobtained by altering the attachment element's shape from rectilinear toa loop shape due to heat induced shape memory effect.

Yet other patent literature relates to devices for endoscopicapplication of surgical staples adapted to attach surgical mesh to abody tissue.

An example of such a teaching is to be found in U.S. Pat. No. 5,364,004,U.S. Pat. No. 5,662,662, U.S. Pat. No. 5,634,584, U.S. Pat. No.5,560,224, U.S. Pat. No. 5,588,581 and in U.S. Pat. No. 5,626,587.

There are a few patent and patent applications teaching the deploymentof patches. For example U.S. Pat. No. 5,836,961 which relates to anapparatus used for developing an anatomic space for laparoscopic herniarepair and a patch for use therewith. The apparatus of U.S. Pat. No.5,836,961 comprises a tubular introducer member having a bore extendingtherethrough. A tunneling shaft is slidably mounted in the bore and hasproximal and distal extremities including a bullet-shaped tip. A roundedtunneling member is mounted on the distal extremity of the tunnelingshaft. The apparatus comprises an inflatable balloon. Means is providedon the balloon for removably securing the balloon to the tunnelingshaft. Means is also provided for forming a balloon inflation lumen forinflating the balloon. The balloon is wrapped on the tunneling shaft. Asleeve substantially encloses the balloon and is carried by thetunneling shaft. The sleeve is provided with a weakened region extendinglongitudinally thereof, permitting the sleeve to be removed whereby theballoon can be unwrapped and inflated so that it lies generally in aplane. The balloon as it is being inflated creates forces generallyperpendicular to the plane of the balloon to cause pulling apart of thetissue along a natural plane to provide the anatomic space.

More patent literature can be found in PCT no. WO08065653 which relatesto a device especially adapted to deploy a patch within a body cavity.The device is an elongate open-bored applicator (EOBP) and comprises (a)at least one inflatable contour-balloon, (b) at least one inflatabledissection balloon. The inflatable contour-balloon and the inflatabledissection balloon are adjustable and located at the distal portion. TheEOBP additionally comprises (c) at least one actuating means located atthe proximal portion. The actuating means is in communication with theinflatable contour-balloon and the inflatable dissection balloon. Theactuating means is adapted to provide the inflatable contour-balloon andthe inflatable dissection balloon with independent activation and/orde-activation.

Although all the above described patents and patent applicationsdemonstrate attachment means or deployment means, none of the literaturefound relates to a reversible connection device which enable areversible coupling between the patch and the patch deployment device.

Thus, there is still a long felt need for a device that will enable areversible connection between the patch and the patch deployment device.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide an activereversible connection (ARC) mechanism adapted to provide a reversibleattachment between a prosthetic patch and a patch deployment device(PDD); wherein said attachment can be actively revered without requiringany application of force on said patch.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said ARC mechanism comprising atleast one connection clip (CC) 107, hinge-like coupled to said PDD,adapted to attach said patch to said PDD: Said CC is characterized byhaving at least three configurations: (i) a horizontal configuration inwhich said CC 107 is substantially horizontal with respect to said PDD100; (ii) a vertical configuration in which said CC 107 is substantiallyvertical with respect to said PDD 100; and, (iii) a free motionconfiguration in which said CC is free to rotate; such that (i) whensaid CC 107 is in said horizontal configuration said attachment betweensaid patch and said PDD is obtained; (ii) when said CC 107 is in saidfree motion configuration said detachment between said patch and saidPDD is obtained.

It is another object of the present invention to provide the ARCmechanism as defined above, additionally comprising at least one lockingbar 203 characterized by at least two configurations: (i) lockconfiguration in which said lock bar 203 maintains said CC 107 in saidhorizontal configuration; and, (ii) free configuration in which saidlocking bar 203 enables said CC 107 a free movement.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said ARC additionally comprising atleast one detachment actuator adapted to reversibly transform saidlocking bar 203 from said lock configuration to said free configuration.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said attachment between said patchand said PDD is obtained once said locking bar 203 is in its said lockconfiguration and said at least one CC 107 is in said horizontalconfiguration such that the same at least partially penetrates saidpatch 210.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said detachment is achieved bytransforming said locking bar from said lock configuration to said freeconfiguration via said at least one detachment actuator.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said detachment actuator comprises awire 206; further wherein said wire 206 is attached to said lock bar203.

It is another object of the present invention to provide the ARCmechanism as defined above, wherein said transformation of said CC 107from said vertical configuration into their said horizontalconfiguration is performed manually by the physician or by the aid of adedicated device.

It is another object of the present invention to provide a method forattaching a prosthetic patch to a patch deployment device (PDD). Themethod comprising steps selected inter alia from:

-   -   a. obtaining an active reversible connection (ARC) mechanism        adapted to provide a reversible attachment between said        prosthetic patch and said PDD; wherein said attachment can be        actively revered without requiring any application of force on        said patch; said ARC comprising        -   i. at least one connection clip (CC) 107, hinge-like coupled            to said PDD, adapted to attach said patch to said PDD: Said            CC is characterized by having at least three            configurations: (i) horizontal configuration in which said            CC 107 is substantially horizontal with respect to said PDD            100; (ii) a vertical configuration in which said CC 107 is            substantially vertical with respect to said PDD 100;            and, (iii) a free motion configuration in which said CC is            free to rotate;        -   ii. at least one locking bar 203 characterized by at least            two configurations: (i) lock configuration in which said            lock bar 203 maintains said CC 107 in said horizontal            configuration; and, (ii) free configuration in which said            locking bar 203 enables said CC 107 a free movement; and,    -   b. providing said CCs in said vertical configuration;    -   c. providing said locking bar in said lock configuration;    -   d. threading said patch through said CC;    -   e. transforming said CC into its said horizontal configuration        thereby providing said attachment between said patch and said        PDD;

It is another object of the present invention to provide the method asdefined above, additionally comprising step of providing said ARC withat least one detachment actuator.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of reversibly transformingsaid locking bar 203 from said lock configuration to said freeconfiguration via said detachment actuator; thereby enabling freerotation of said CC such that detachment between said patch and said PDDis obtained.

It is another object of the present invention to provide the method asdefined above, additionally comprising step of introducing said PDD intoa body cavity.

It is another object of the present invention to provide the method asdefined above, additionally comprising step detaching said patch fromsaid PDD.

It is another object of the present invention to provide the method asdefined above, wherein said detachment additionally comprising steps ofreversibly transforming said locking bar 203 from said lockconfiguration to said free configuration via said detachment actuator;thereby enabling said CC 107 to rotate freely such that said detachmentbetween said patch and said PDD is obtained.

It is another object of the present invention to provide a hernia kituseful in minimal invasive hernia surgery, comprising:

-   -   a. a patch;    -   b. patch deployment device (PDD), adapted to deploy said patch        within the abdominal cavity; and,    -   c. an active reversible connection (ARC) mechanism for        reversible attaching said patch to said PDD;    -   wherein attachment can be actively revered without requiring any        application of force on said patch.

It is another object of the present invention to provide the hernia kitas defined above, wherein said ARC mechanism comprising:

-   -   a. at least one connection clip (CC) 107, hinge-like coupled to        said PDD, adapted to attach said patch to said PDD: Said CC is        characterized by having at least three configurations: (i)        horizontal configuration in which said CC 107 is substantially        horizontal with respect to said PDD 100; (ii) a vertical        configuration in which said CC 107 is substantially vertical        with respect to said PDD 100; and, (iii) a free motion        configuration in which said CC is free to rotate; such that (i)        when said CC 107 is in said horizontal configuration said        attachment between said patch and said PDD is obtained; (ii)        when said CC 107 is in said free motion configuration said        detachment between said patch and said PDD is obtained.

It is another object of the present invention to provide the hernia kitas defined above, additionally comprising at least one locking bar 203characterized by at least two configurations: (i) lock configuration inwhich said lock bar 203 maintains said CC 107 in said horizontalconfiguration; and, (ii) free configuration in which said locking bar203 enables said CC 107 a free movement.

It is another object of the present invention to provide the hernia kitas defined above, wherein said ARC additionally comprising at least onedetachment actuator adapted to reversibly transform said locking bar 203from said lock configuration to said free configuration.

It is another object of the present invention to provide the hernia kitas defined above, wherein said attachment between said patch and saidPDD is obtained once said locking bar 203 is in its said lockconfiguration and said at least one CC 107 is in said horizontalconfiguration such that the same at least partially penetrates saidpatch 210.

It is another object of the present invention to provide the hernia kitas defined above, wherein said detachment is achieved by transformingsaid locking bar from said lock configuration to said free configurationvia said at least one detachment actuator.

It is still an object of the present invention to provide the hernia kitas defined above, wherein said detachment actuator comprises a wire 206;further wherein said wire 206 is attached to said lock bar 203.

It is lastly an object of the present invention to provide the herniakit as defined above, wherein said transformation of said CC 107 fromsaid vertical configuration into their said horizontal configuration isperformed manually by the physician or by the aid of a dedicated device.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1A illustrates an example of a PDD 100 which comprises said ARCmechanism.

FIGS. 2A-2D illustrate the internal operation of said ARC mechanism.

FIGS. 3A-3D illustrate a method of using said ARC mechanism forproviding said reversible connection between said patch and said PDD100.

FIG. 4A-4H Illustrate an embodiment of a stapling apparatus SA 400adapted for providing a reversible connection by the ARC mechanism.

FIG. 5 illustrates an embodiment of a staple return spring SRS 500.

DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of the invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications, however,is adapted to remain apparent to those skilled in the art, since thegeneric principles of the present invention have been definedspecifically to provides means and method for creating a reversible andactive connection between a patch and a patch deployment device.

The present invention provides an active reversible connection mechanism(ARC) between a prosthetic patch and a patch deployment device (PDD)wherein said connection can be performed during a surgery at a standardsurgery room by the medical staff.

Furthermore, the present invention provides means so as to enable thesurgeon to actively eliminate said attachment once detachment betweensaid PDD and said patch is necessary.

It should be emphasized that some of the major advantages of the presentinvention, with respect to the prior art, is to provide a fast andintuitive method for creating a reliable connection between a patch anda PDD in the surgery room.

In addition, the present invention provides means to actively disconnectsaid patch from said PDD, when said disconnection is desired without theneed to exert large forces on said patch and/or said tissue.

The term “Hernia” refers hereinafter for umbilical hernia, hiatalhernia, ventral hernia, postoperative hernia, epigastric hernia,spiegelian hernia, inguinal hernia and femoral hernia, generally anyabdominal wall related hernia.

The term “hinge” or “hinge-like connection” refers hereinafter as to atype of bearing that connects two solid objects, typically allowing onlya limited angle of rotation between them. Two objects connected by anideal hinge rotate relative to each other about a fixed axis of rotation(the geometrical axis of the hinge). Hinges may be made of flexiblematerial or of moving components.

The term “hinge like connection” can refer to a standard hinge or to aliving hinge (i.e., a thin flexible hinge (flexure bearing) made fromplastic that joins two rigid parts together while allowing them to bendalong the line of the hinge).

The term ‘controlled deployment’ refers hereinafter to a patchdeployment which is continuous; i.e., the deployment is not binary butanalogous—there are several deployment levels. This is in contrast soconventional deployment system is now days (see for example U.S. Pat.No. 5,370,650), in which the deployment of the patch relies upon theelasticity of a loop member surrounding the patch such that the patchcan be either fully folded or fully unfolded. No intermediate areenabled. In the present invention there can be several deploymentstages.

The term ‘bidirectional’ or ‘fully reversible deployment’ refershereinafter to the deployment of the patch, which according to thepresent invention, is fully reversible. In other words, the patchdeployment is bidirectional, i.e., the patch can be fully folded (i.e.,deployed within the body) and then, if the surgeon desires, the patchcan be fully unfolded simply by the reconfiguration of the flexible armsfrom the initial stage to the final stage and vice versa.

The term “minimally invasive surgery” refers hereinafter to proceduresthat avoid open invasive surgery in favor of closed or local surgerywith fewer traumas. Furthermore, the term refers to a procedure that iscarried out by entering the body through the skin or through a bodycavity or anatomical opening, but with the smallest damage possible.

The term “articulation” refers hereinafter to a joint or juncturebetween two segments of the device. The articulating means of thepresent invention provides the ability to better adjust the device tothe curvature of the treated tissue.

The term “orientation” refers hereinafter to the rotation of the meshwithin the abdominal cavity so as to fit to the hernia. Usually the meshis not symmetric in shape (i.e., rectangular or i.e., ellipse)—thereforeit has different directions. By rotating the mesh within the abdominalcavity—one can decide which direction is turned where.

The term “adjusting” refers hereinafter to rolling, folding and windingof the patch, thus preparing and enabling the insertion of said patchinto the abdominal cavity.

The term “active reversible connection” refers hereinafter to a couplingbetween the patch and the patch deployment device PDD in which thecoupling/decoupling between the patch and the PDD is enabled by an actperformed by the user (namely the physician). Once said User performedsaid act, said coupling/decoupling is canceled.

According to the present invention the coupling/decoupling is obtainedactively via the aid of dedicated connection clips (CC) which arecharacterized by at least two configurations:

-   -   (a) substantially horizontal/parallel configuration (in which an        attachment between the patch and the PDD is provided);    -   (b) substantially vertical configuration; and,    -   (c) a configuration in which the CCs are free to rotate.

Before explaining the figures, it should be understood that theinvention is not limited in its application to the details ofconstruction and the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The invention canbe carried out in various ways.

Reference is now being made to FIG. 1A illustrates an example of a PDD100 which comprises said ARC mechanism.

PDD 100 is defined hereinafter as a surgical device which can introducea patch into a body cavity of a patient; PDD 100 can deploy said patchsuch that it is at least partially spared inside the body cavity;alternatively PDD 100 can only introduce said patch into the body cavitywithout performing any deployment.

In general, PDD 100 comprises at least two portions: a distal portion101 and a proximal portion 102. The proximal portion is adapted toremain outside the body, adjacently to the user and the distal portion101 is adapted to be inserted into the body.

The distal portion comprises at least one frame arm (FA) 104 to whichthe patch is attached. Each FA 104 comprises said ARC mechanism whichprovide reversible attachment between each FA 104 and the patch 106 suchthat said patch can be rolled/folded on said distal portion 101, andinserted into the patient's body cavity through a laparoscopic cannulaor a small incision.

It should be noted that the term reversible refers hereinafter to theability to both attach the patch to the PDD and to decouple the samefrom the PDD.

Said ARC mechanism comprises at least one connection clip (CC) 107. SaidCC is coupled to said FA 104 by hinge tab 132. Said ARC is covered bycover 131 which is attached to the FA 104. Cover 131 comprises at leastone hinge tab 132 which is adapted to hold said CC 107 attached to FA104 an to serve as a hinge allowing free rotation of said CC 107. Saidhinge tab 132 is inserted through hinge hole 133, located at CC 107 andthrough hole 134, located at FA 104.

Reference is now being made to FIGS. 2A-2D which illustrate the internaloperation of said ARC mechanism. For the purpose of illustration only,cover 131 is removed from these drawings.

A locking bar 203 is located inside groove 204 at FA 104. Said lockingbar 203 can move linearly inside said groove 204 and comprises at leastone groove 205. Said locking bar 203 is characterized by at least twopositions: free position, in which each of said groove/s 205 issubstantially located below said CC 107 (see FIGS. 2C and 2D), and lockposition, in which said groove 205 is located away from said CC 107 (seeFIGS. 2A and 2B).

In the lock position of the locking bar 203, the CC 107 aresubstantially perpendicular to the FA 104; and in free position of thelocking bar 203, the CC 107 are free to rotate (hence, as will bediscussed hereinafter a detachment is enabled).

A disconnection wire 206 is attached to said locking bar 203. Said wire206 can be pulled proximally to the proximal portion 102 and is adaptedto transform said locking bar 203 from its said lock position into itssaid free position.

According to this embodiment, each CC 107 comprises at least 3 sections:protruding portion (PP) 201 adapted to protrude through said patchduring said connection process, hinge hole 133, and locking tab 202which is tilted toward FA 104.

Each of said CC 107 is characterized by at least two configurations:horizontal/parallel configuration in which said CC 107 is substantiallyhorizontal and parallel to said FA 104 (FIGS. 2B, 2C) and verticalconfiguration in which said CC 107 is substantially vertical withrespect to said FA 104 (FIGS. 2A and 2D).

At least one holding hole 207 is located at said locking bar 203 and isadapted to hold said CC 107 in its vertical configuration.

At least one niche 208 in located at FA 104 adapted to accommodate saidlocking tab 202 of said CC 107 while the last is in its saidhorizontal/parallel configuration.

Reference is now being made to FIGS. 3A-3D illustrating a method ofusing said ARC mechanism in order to provide said reversible connectionbetween said patch and said PDD 100. Again, for the purpose ofillustration only, cover 131 was removed from these drawings.

FIG. 3A illustrates the initial state of said ARC mechanism in which allof said CC 107 are in their vertical configuration and said locking bar203 is positioned in said lock position.

As can be seen in the figure, said locking tab 202 of each said CC 107is located inside said holding hole 207, therefore each CC 107 is heldin its said vertical configuration and can penetrate a patch 210 whilstthe last is mounted on top of said PDD (see FIG. 3B).

Once said patch is mounted, each of said CC 107 is transformed from saidvertical configuration into their said horizontal configuration (seeFIG. 3C).

Said transformation can be achieved either manually (i.e., the physicianwill manually rotate the CCs 107 thereby transform them from saidvertical configuration into their said horizontal configuration) or bythe aid of a dedicated device.

Once said CC 107 is transformed to its horizontal configuration whilesaid locking bar is in its said lock position, said locking tab 202 issprigged into niche 208. Since the locking tab 202 is titled inwardly,if said CC 107 is pulled upwardly in this state, the locking tab 202 isstooped by the upper edge of said locking bar 203, therefore, therotation back to said vertical configuration of said CC 107 is limitedby said locking bar 203 and said CCs 107 are locked in said horizontalconfiguration, holding said patch attached to said FA 104.

It should be pointed out that it is a unidirectional mechanism. In otherwords, if one tries to force CCs 107 to its vertical configuration,locking tabs 202 will ‘bump into’ locking bar 203.

By further pulling said locking bar 203 towards the proximal portion theCCs 107 are unlocked and can be rotated be back to its verticalconfiguration (see FIGS. 3D and 3E).

Once detachment between said patch 210 and said PDD in desired, lockingbar 203 is pulled backward by wire 206, changing the position of saidlocking bar form its said lock position into its said free position (seeFIG. 3D). In said free position of the locking bar 203, the CCs 107 arefree to rotate (hence, as will be discussed hereinafter, a detachmentbetween the PDD and the patch is enabled).

Once locking bar 203 is positioned in said free position, said groove/s205 is located below said CC/s 107, therefore said locking bar 202 is nolonger limiting the movement of said CC/s 107 enabling their freemovement. In this state, detachment can be obtained by simply pullingsaid FA 104 away from said patch; as a result, said CC/s 107 rotate backinto their said vertical configuration and are released from said patch(see FIG. 2E).

Reference is now made to FIG. 4A-4H, which illustrate an embodiment of astapling apparatus SA 400 adapted for providing said reversibleconnection by said ARC mechanism. Said SA 400 comprises a frame 401which holds the distal portion 101 of a PDD 100. Four staplers 403 areconnected to the frame 401 at each cornet by four separate hinges(either standard or living hinges). Each said stapler 403 is adapted topush down the patch 210 through a pair of CC 107 and to transform saidCCs 107 from a vertical position into a horizontal position (thusproviding said reversible connection). Stapling presses 404 are locatedat the end of each stapler inside groove 405 and adapted to push CC 107into horizontal position. Each pair of staplers 403 is connected viabridge 407 in order to prevent lateral movement of said staplers 403during the stapling process. A snap groove 406 is located at the centerof the frame 401 and adapted to reversibly hold said PDD 100 attached toSA 400 until said reversible attachment is obtained.

Each pair of CC 107 is held in a vertical position by clip holder (CH)402. Each said CH 402 is adapted to hold a pair of CC 107 in verticalposition in order to allow its insertion through the patch 210 duringthe stapling process. In addition, CH 402 is adapted the hold the clipsvertical during shipment in order to allow stapling in the operationroom without the need of any preparation. As illustrated in FIGS. 4B-4C,each CH 402 comprises two grooves 408 which hold the CC 107 in avertical position. Once stapling process is preformed and the surgeon islowering the stapler 403 toward the patch, each CH 402 is pushed downand as a result it is also moving laterally. In this state, since the CC107 are extracted from groves 408, their transformation from verticalinto horizontal position is enabled; said lateral movement of said CH402 is obtained as bulge 409 at CH 402 is sliding along bulge 410 at thestapling frame 401 during the down movement of CH 402.

FIGS. 4D-4G illustrate the process of connecting the patch 210 to onepair of CC. At the initial stage (FIG. 4D) the CCs are held verticallyby CH 402. Next, a patch 210 is places on top of the stapling apparatus(FIG. 4E); the stapler 403 is then lowered toward the patch 210 by thesurgeon (or other member of the medical staff); as a result the two CC107 are penetrating through patch 210 and into groove 405 (FIG. 4F).During the initial penetration, CC 107 are held by CH 402, thuspremature transformation from vertical into horizontal position isprevented. Once the CC 107 are completely inserted into said patch 210,CH 402 is positioned laterally relative to the CC 107 (as also describedis FIGS. 4B-4C); at this stage the surgeon push on stapler press 404 andlower it toward CC 107 (FIG. 4G), as a result CC 107 position istransformed form vertical position into horizontal position. Since thesaid lock bar 203 is located at its said lock position, once CC 107 aresubstantially horizontal position, they are locked in this stage, thusproviding said reversible connection between patch 210 and PDD 100. Oncesaid connection is obtain with all CC 107, PDD is removed from SA 400.

FIG. 4H illustrates the configuration of SA 400 during shipment. Inorder to reduce package volume during shipment and to keep the deviceready for stapling, at least one, preferably two, packaging caps 411 areutilized. Said caps 411 are reversibly attached to the frame 401, andadapted to retain stapler 403 in a substantially horizontal positionduring device shipment. In addition said caps 411 also prevent downmovement of stapler press 404, prevent lateral movement of CH 402 andprevent non-deliberate extraction of PDD 100 from frame 401.

Once the device in removed from its packaging during the surgery, saidpack caps 411 are removed by the medical staff in order to allowstapling of the patch 210 to the PDD 100. Once the caps 411 are removed,the staplers 403 springs into horizontal position allowing the placementof patch 210 onto the SA 400 and PDD 100.

In order to allow tight spreading of the patch 210 during surgery, saidstapling process is preformed while PDD 100 is not completely opened; asa result, once PDD is completely opened inside the abdominal cavity, itis stretched beyond its original dimension (as was during stapling)therefore tight spreading is obtained.

Reference is now being made to FIG. 5 which illustrates an embodiment ofa staple return spring SRS 500. In general, SRS is needed in order toreturn CC 107 into horizontal position immediate after detachment fromthe patch 210; this is necessary in order prevent damage to internalorgans by the sharp tip of CC 107 and in order to prevent CC 107 frombeing caught at the trocar or at the tissue during device extraction.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

1. A system for closing an aperture in a biological tissue, the systemcomprising: a handle; an elongate shaft connected to the handle; adeployment scaffold connected to the shaft; and a plurality ofattachment members connected to the scaffold, wherein the attachmentmembers are configured to releasably retain a surgical implant, andreleasing the implant from the scaffold comprises actively transformingthe attachment members from a retaining configuration to a releasingconfiguration.
 2. The system according to claim 1, further comprising alocking mechanism that is operably linked with each of the plurality ofattachment members.
 3. The system according to claim 2, wherein thelocking mechanism is adapted to reversibly lock the attachment members,wherein when the locking mechanism is in a locked configuration, theattachment members are held in the retaining configuration and when thelocking mechanism is in an unlocked configuration, the attachmentmembers are transformed to the releasing configuration.
 4. The systemaccording to claim 1, wherein the scaffold comprises: a plurality ofarms that are configured to move from a retained position to at leastone deployed position, wherein the attachment members are connected tothe arms.
 5. The system according to claim 4, wherein the arms areflexible.
 6. The system according to claim 4, wherein the arms arerigid.
 7. The system according to claim 4, wherein the number ofattachment members is independent of the number of arms.
 8. The systemaccording to claim 1, wherein the scaffold comprises: a frame; and aplurality of deployment arms hingedly connected to the frame, whereinthe frame is configured to move from a retained position to at least onedeployed position, and the attachment members are connected to the arms.9. The system according to claim 1, wherein the deployment scaffold isconfigured to allow for deployment of the implant and retraction of theimplant while the implant is within a patient's body.
 10. The systemaccording to claim 1, wherein the deployment scaffold is configured toallow for a plurality of deployment positions.
 11. The system accordingto claim 1, wherein the deployment scaffold comprises an articulatingmember that allows for adjustment of the position and the orientation ofthe surgical implant relative to the aperture in the tissue.
 12. Thesystem according to claim 10, wherein the articulating member allows forvertical flexibility of the deployment scaffold in order to press theimplant against the tissue.
 13. The system according to claim 1, furthercomprising the surgical implant.
 14. The system according to claim 13,wherein the implant is connected to the system in an operating room. 15.The system according to claim 13, wherein the surgical implant is apatch.
 16. The system according to claim 15, wherein the patch iscomprised of surgical mesh.
 17. The system according to claim 1, whereinthe elongate shaft is flexible.
 18. The system according to claim 1,wherein the elongate shaft is rigid.
 19. The system according to claim1, wherein the aperture in the biological tissue is an aperture in anabdominal wall.
 20. The system according to claim 1, wherein deploymentis accomplished by liner movement of the shaft with respect to thehandle.
 21. The system according to claim 1, further comprising anattachment member return mechanism, wherein the mechanism assists intransforming the members to the retaining configuration once the implantis detached from the system.
 22. A method for closing an aperture in abiological tissue, the method comprising: inserting into a surgical siteof a patient an instrument having an elongate shaft and a deploymentscaffold connected to the elongate shaft, wherein the deploymentscaffold is configured to releasably retain a surgical implant;deploying the surgical implant; actively transforming attachment membersconnected to the scaffold from a closed configuration to an openconfiguration, thereby releasing the implant from the instrument; andattaching the implant to the biological tissue, thereby covering theaperture in the tissue.
 23. The method according to claim 19, whereinprior to the inserting step, the method further comprises attaching thesurgical implant to the instrument.
 24. The method according to claim22, wherein attaching comprises: contacting the implant to thedeployment scaffold of the instrument such that the implant may bepierced by the attachment members connected to the scaffold; contactingthe deployment scaffold holding the implant to a stapling device;engaging the stapling device to cause the attachment members to piercethe implant and to transform the attachment members from a releasingconfiguration to a retaining configuration; and disconnecting theinstrument from the plurality of staplers.
 25. The method according toclaim 24, wherein the deployment scaffold is in a partially closedconfiguration when it is contacted to the stapling device, therebyallowing for stretching of the implant when the scaffold is in an openconfiguration.
 26. The method according to claim 24, wherein thestapling device temporarily holds the attachment members in a releasingconfiguration in order to facilitate piercing of the implant by theattachment members.
 27. The method according to claim 22, wherein priorto the transforming step, the method further comprises adjusting theposition and the orientation of the implant relative to the aperture inthe tissue.
 28. The method according to claim 22, wherein the aperturein the biological tissue is an aperture in an abdominal wall.
 29. Themethod according to claim 22, wherein deploying is accomplished in acontrolled and continuous manner.
 30. The method according to claim 22,wherein prior to the transforming step, the method further comprises:assessing the deployment of the implant relative to the aperture in thetissue; retracting the implant; and re-deploying the implant.
 31. Themethod according to claim 22, wherein the transforming and the attachingsteps are performed sequentially.
 32. The method according to claim 22,wherein the transforming and the attaching steps are performedsimultaneously.
 33. A device for attaching an implant to a surgicalinstrument, the device comprising: a plurality of staplers, wherein thestaplers are adapted to reversibly connect a patch to a deploymentdevice through a clip; and at least one stabilizing bar connecting atleast two of the staplers.
 34. The device according to claim 33, whereinthe stabilizing bar is removable from the staplers.
 35. The deviceaccording to claim 33, comprising: a frame; a first set of two staplersthat are arranged parallel to each other connected to the frame; asecond set of two staplers that are arranged parallel to each otherconnected to the frame, wherein the first and second set are arrangedsuch that a stapling end of each of the staplers in the first set facesa stapling end of each of the staplers in the second set; a firststabilizing bar connecting across a top of each of the staplers in thefirst set; and a second stabilizing bar connecting across a top of eachof the staplers in the second set.
 36. The device according to claim 33,wherein a bottom portion of each of the staplers is configured totemporarily hold attachment members of an instrument in a configurationthat facilitates piercing of an implant by the attachment members. 37.The device according to claim 33, further comprising packaging caps thatcompress the staplers during shipping.
 38. A kit, the kit comprising: asystem for closing an aperture in a biological tissue, the systemcomprising: a handle; an elongate shaft connected to the handle; adeployment scaffold connected to the shaft; and a plurality ofattachment members connected to the scaffold, wherein the attachmentmembers are configured to releasably retain a surgical implant, andreleasing the implant from the scaffold comprises actively transformingthe attachment members from a retaining configuration to a releasingconfiguration; and a device for attaching an implant to a surgicalinstrument, the device comprising: a plurality of staplers, wherein thestaplers are adapted to reversibly connect a patch to a deploymentdevice through a clip; and at least one stabilizing bar connecting atleast two of the staplers.
 39. The kit according to claim 38, whereinthe aperture closing system is connected to the implant attachmentdevice.
 40. The kit according to claim 39, wherein the deploymentscaffold of the aperture closing system is connected to the implantattachment device in a partially deployed configuration.